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Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY (ANTEY)

30. juni 2020 opdateret af: National Research Center for Preventive Medicine

Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study

A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale.

Primary Study Objective(s) Primary study objective The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study).

  1. Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
  2. Evaluation of actual patient adherence to OACs

Secondary Study Objective(s)

  1. Evaluation of potential patient adherence to OACs
  2. Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
  3. Validation of new original 5-item Questionnaire
  4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

AF patients from ongoing PROFILE registry will be invited to visit the scientific center.

2 visits with a 6-month interval are expected for each patient as part of routine clinical practice and phone contact is scheduled for each patient 1 year from the first visit to the scientific center (follow-up period).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

201

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.

Beskrivelse

Inclusion Criteria:

  • Men and women above 18 years of age who were included in the PROFILE registry by the start of the observational study
  • Presence of written informed consent to participate in the study, fill in the study questionnaires and have personal data analyzed
  • Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK

Exclusion Criteria:

  • Patients with high bleeding risk, including patients with:

    • Congenital or acquired bleeding disorders
    • Uncontrolled resistant hypertension
    • Exacerbation of gastric and duodenal ulcer
    • Vascular retinopathy
    • Recent history of intracranial or intracerebral hemorrhage
    • Pathology of the brain and spinal cord vessels
    • Recent history of brain, spinal cord or eye surgery
    • History of bronchiectasis or pulmonary hemorrhage
    • A CHA2DS2-VASc score of 0 (OACs are not indicated)
    • Pregnancy, lactation
    • Planned surgery
    • Known hypersensitivity to ingredients of medications used in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
Tidsramme: 6 months

The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.

Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.
6 months
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
Tidsramme: 1 year

The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.

Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.

Out of 201 participants of the study 4 patients died and 197 patients completed the study.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Potentially Adherent Patients
Tidsramme: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Proportion of OACs Prescribed by Doctors According to Guidelines
Tidsramme: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

Prescription of OACs according to guidelines was considered "positive" if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation.

  1. Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more.
  2. Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more.
  3. Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk.
  4. NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C).
  5. In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
The Main Reasons for Refusing to Start NOAC Therapy
Tidsramme: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
Tidsramme: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
Tidsramme: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Research Center for Preventive Medicine

Efterforskere

  • Ledende efterforsker: Sergey Martsevich, MD,PhD, National Research Center of Preventive Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. september 2017

Primær færdiggørelse (Faktiske)

28. december 2018

Studieafslutning (Faktiske)

28. december 2018

Datoer for studieregistrering

Først indsendt

28. december 2018

Først indsendt, der opfyldte QC-kriterier

29. december 2018

Først opslået (Faktiske)

2. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ANTEY

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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